Nanjing Anjian Medical Device Co., Ltd.
Registered establishment in Nanjing, Jiangsu, China. 22 device types.
Nanjing Anjian Medical Device Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Bag, Stomal, Syringe, Piston and 20 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | NANJING ANJIAN MEDICAL DEVICE CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015142802 |
| FEI number | 3015142802 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 南京安简医疗器械有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | Building 9 No. 16 Xinggu Road Guli Street Jiangning District |
| Postal code | 211100 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bag, Drainage, With Adhesive, Ostomy | Class 1 | Ostomy Pouch, Ostomy Bag | 2024 | 49 |
| Bag, Stomal | Class 1 | Ostomy Pouch Deodorant | 2024 | 7 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Urinary Leg Bag, Urine Bag | 2024 | 52 |
| Bandage, Elastic | Class 1 | Conforming Stretch Gauze | 2024 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | Skin barrier film | 2018 | 41 |
| Catheter, Retention Type, Balloon | Class 2 | Disposable Silicone Foley Catheter, Silicone Foley Catheter | 2024 | 17 |
| Catheter, Straight | Class 2 | PVC Urethral Catheter | 2024 | 21 |
| Catheter, Urethral | Class 2 | Intermittent Catheter, Hydrophilic Catheter | 2024 | 11 |
| Collector, Ostomy | Class 1 | Ostomy Pouch Deodorant | 2024 | 18 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Prep Pad, Alcohol Pad | 2026 | 197 |
| Dressing, Wound, Drug | Class U | Antimicrobial Gauze, Antimicrobial Gauze Wound Dressing, Silver Alginate Strip, Silver Silicone Foam Dressing, Xeroform Dressing, Silver Foam Dressing and 1 more | 2024 | 48 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | Class 1 | Hydrogel Gauze | 2024 | 118 |
| Dressing, Wound, Hydrophilic | Class 1 | Super Absorbent Dressing, Foam Dressing, High Absorbent Pad, Silicone Transparent Dressing, Silicone Foam Dressing, Fibergel Dressing and 5 more | 2018 | 195 |
| Dressing, Wound, Occlusive | Class 1 | Hydrocolloid Dressing | 2024 | 183 |
| Lubricant, Patient | Class 1 | Sterile Lubricate Jelly | 2024 | 33 |
| Needle, Hypodermic, Single Lumen | Class 2 | Sterile Syringe with Needle, Insulin Syringe, Insulin Syringe with Safety Retractable | 2026 | 71 |
| Protector, Ostomy | Class 1 | Ostomy skin barrier paste, Ostomy Skin Barrier Strip, Ostomy Skin Barrier Ring, Ostomy Skin Barrier Arc, Curved Tail Closure, Ostomy adhesive remover wipe and 9 more | 2024 | 33 |
| Solvent, Adhesive Tape | Class 1 | Adhesive remover wipe | 2018 | 20 |
| Syringe, Antistick | Class 2 | Sterile Syringe with Needle, Insulin Syringe, Insulin Syringe with Safety Retractable | 2026 | 39 |
| Syringe, Piston | Class 2 | Sterile Syringe with Needle | 2026 | 60 |
| Tape And Bandage, Adhesive | Class 1 | Catheter Stabilization Device, Silicone Tape | 2024 | 353 |
| Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) | Class 2 | Catheter Insertion Tray, Self Catheterization Kit | 2024 | 11 |
Clearances
No clearance names Nanjing Anjian Medical Device Co., Ltd. as applicant. 15 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K202570 | 2021-07-02 | MEG | Traditional | Jiangsu Micsafe Medical Technology Co., Ltd. |
| K181478 | 2019-09-13 | FRO | Traditional | Roosin Medical Co., Ltd. |
| K183665 | 2019-09-06 | MEG | Traditional | Jiangsu Micsafe Medical Technology Co., Ltd. |
| K181315 | 2019-02-14 | FRO | Traditional | Winner Medical Co., Ltd. |
| K170077 | 2017-03-30 | FRO | Traditional | Huizhou Foryou Medical Devices Co., Ltd. |
| K143335 | 2015-06-01 | FRO | Traditional | Roosin Medical Devices Co., Ltd. |
| K140954 | 2015-03-23 | FRO | Traditional | Huizhou Foryou Medical Devices Co., Ltd. |
| K142563 | 2014-10-28 | EZD | Traditional | Well Lead Medical Co., Ltd. |
| K130908 | 2013-10-03 | EZL | Traditional | Guangdong Baihe Medical Technology Co., Ltd. |
| K120181 | 2013-02-14 | FRO | Traditional | Huizhou Foryou Medical Devices Co., Ltd. |
| K112110 | 2012-04-10 | KMJ | Traditional | Jianerkang Medical Dressing Company |
| K111405 | 2012-02-13 | GBM | Traditional | Hangzhou Bever Medical Devices Co., Ltd. |
| K082815 | 2008-10-08 | EZL | Traditional | Well Lead Medical Instruments |
| K030664 | 2003-05-23 | FCM | Traditional | Amsino Medical Inc. |
| K030712 | 2003-05-23 | FCM | Traditional | Amsino Medical Inc. |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.